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in Spain on MPN

Friday,12th May

Optimizing interferon treatment in PV

H.Gisslinger

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Incyte (INCY) Q1

Jakafi sales grew 37%, year over year to $251 million

Product royalty revenues from Novartis NVS for the commercialization of Jakafi in ex-U.S. markets surged 31.8% to $29 million.

2017 Outlook

The company continues to expect Jakafi revenues in the range of $1,020¡V$1,070 million

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Incyte (INCY) stock toppled to a 10-week low Friday on a fourth consecutive quarter of losses, but it was curiously among a slew of biotechs to grab bullish reports from a Credit Suisse analyst in the wake of earnings.

Analyst Alethia Young kept her outperform rating on Incyte stock, saying the company¡¦s chemotherapy drug, Jakafi, will pull in $1.068 billion in 2017 sales, growing to $1.86 billion in 2022. On Thursday, Incyte said it expected $1.02 billion to $1.07 billion in 2017 sales of Jakafi.

http://www.investors.com/news/technology/which-biotechs-are-grabbing-bullish-post-q1-views-heres-some-incyte/?src=A00220&yptr=yahoo

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WhatsApp

ÃĵØÃÄ¡]6446¡^¬Q¡]1¡^¤éªí¥Ü¡A¤w©ó4¤ë28¤é±µÀò¼Ú¬w¹Ù¦ñAOP³qª¾¡A¼Ú·ùEMA±N¨Ó¥x¬d®ÖÃĵØÂåÃÄ¥x¤¤¼t¡A°õ¦æªøªL°êÄÁ«ü¥X¡A¦¹¶µ³qª¾¥NªíP1101ªvÀøPV¡]¯u©Ê¬õ¦å²y¡^·sÃÄ¡A¤W¥«¶i«×«ùÄò¦V«e±À¶i¡A©ú¦~¨úÃÒ¥i´Á¡C

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ÃĵØÂåÃÄ¥x¤¤¤À¤½¥qÀç¹Bªø÷á­l´É«ü¥X¡A¤W¥«ÃĪ«ªº«~½è»P¦w¥þ¡AEMA­q¦³ÄYÂÔªº¬d¼t³W½d¡A¤×¨ä³J¥Õ½èÃĪ«ªº²£»s¤S¸û¤p¤À¤l¤Æ¾ÇÃĪ«§xÃø¡A¹ïª«¤Æ©Ê½è¡B«~½è«OÃҤδú¸Õ¤è¦¡¡]CMC¡^ªº¥Í²£½]¬d­n¨D§ó°ª¡A¦]¦¹¹ï¥x¤¤¼tªº¹ê¦a¬d®Ö»{ÃÒ¬OPV·sÃÄÄ~¦¨¥\§¹¦¨¤T´ÁÁ{§É¸ÕÅç«á¡AÁÚ¦V°Ó·~¤Æ¶q²£¤W¥«ªºÃöÁä³Ì«á¤@­ù¡C

Ãĵؤµ¦~ªì¥D°ÊÁܽЫe­^°êÃĪ«»P«O°·²£«~ªk³WºÞ²z§½¡]MHRA¡^°ª¯Å¼f¬d­ûRichard Funnel¶i¦æ¬°´Á¤@¶gªº¼ÒÀÀ¬d¼t¡]mock inspection¡^¡C

¦b¬d®Ö¥x¤¤¼t«á¡AFunnel»{¬°¥x¤¤¼tµL½×¦b¤u¼t³]¸m¡B¤H­û¯À½è¤Î¹ïGMP·§©Àµ¥©Ò¦³³nµw³]¬I¤è­±³£¨S¦³¥ô¦óÄY­«¡]Critical¡^¯Ê¥¢¡A¥çµL¥ô¦óªº­«­n¡]Major¡^¯Ê¥¢¡A¶È³¡¤À¦¸­n¯Ê¥¢¥i¥H¶i¦æ§ïµ½¡C

¦¹¥~¡AÃĵØÃĪº°w¾¯¥R¶ñ¥N¤u¼w°ÓVetter Pharma¤]©ó¤µ¦~3¤ë¶¡±Mµ{­u¥x¤¤¼t¶i¦æ¼ÒÀÀ¬d¼t¡C

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·|­û¡G°¶¤j¤j10136951  µoªí®É¶¡:2017/4/29 ¤U¤È 11:28:15²Ä 2222 ½g¦^À³
AOP©xºô¡AÁÙ¦³2­«ÂI

1.¨Ï¥ÎP1101ªvÀøPV«ùÄò©ÊÅã¥Ü¥X:¥O¤H«HªAªº¦³®Ä¡B¦w¥þ¡B­@¨ü©Ê¡A¤è«K©Ê©M¦X¥G³W©w(¼Ð·Ç)

2.AOP¬ã¨s(¹êÅç)©Ò±oªºµ²ªG¤Î¸ê®Æ¡A±N¥ÑÃĵئVFDA¥Ó½Ð¬ü°êÃÄÃÒ

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·|­û¡G°¶¤j¤j10136951  µoªí®É¶¡:2017/4/29 ¤U¤È 11:23:06²Ä 2221 ½g¦^À³
AOP Orphan Pharmaceuticals AG announces start of EMA marketing authorization application procedure for Ropeginterferon alfa-2b in Polycythemia Vera

EMA started the centralized marketing authorization procedure for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) on Feb 23rd 2017.


Ropeginterferon alfa-2b is a novel mono-pegylated interferon with an improved every-two-week application schedule and orphan designation in Europe and the U.S.


AOP´s development program in PV consistently demonstrated convincing efficacy, safety, tolerability, convenience and compliance.


Data from AOP´s development program will be presented to U.S. FDA for approval for commercialization in the U.S. by PharmaEssentia.

http://www.aoporphan.com/news-media/press-release/aop-newscenter-detail-page/artikel/aop-orphan-pharmaceuticals-ag-announces-start-of-ema-marketing-authorization-application-procedure-for-ropeginterferon-alfa-2b-in-polycythemia-vera.html

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http://www1.cde.org.tw/ct_taiwan/search_case2.php

ºô­¶Åã¥Üp1101+Ribavirin C¨x3´ÁÁÙ¦A¶i¦æ¤¤¡A¹w´Á°õ¦æ´Á¶¡2017/07/31¡A¨ºP1101+¤p¤À¤lSovaldi¤£ª¾¦³µL­n¦A¶i¦æ?

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Kiladjian Can we alter MPN evolution with IFN therapy?

²³ø¤º®e¡G

Selectiveimpact of IFN(²Ä18­¶)

AOP2014 / P1101 vs. JAK2V617F(²Ä19­¶)

AOP2014/P1101 specifically targets JAK2V617F erythroïd progenitors in vitro

AOP2014 / P1101 vs. JAK2V617F(²Ä20­¶)

In vivo: PROUD-PV cohort

•13 (of 257) patients randomizedin France (5 AOP2014, 8 HU)

•Evolution of %JAK2V617F:

AOP2014 / P1101 vs. JAK2V617F(²Ä21­¶)

In vivo: PROUD-PV cohort

•BM progenitors could be studiedin 10/13 French pts, 3 treated wit hAOP2014 and 7 with HU

•ratio of the proportions of EECs after and before treatment

AOP2014 / P1101 vs. JAK2V617F(²Ä22­¶)

In vivo: PROUD-PV cohort

•BM progenitors could be studiedin 10/13 French pts, 3 treated with AOP2014 and 7 with HU

•ratio of mutant to wild-type JAK2colonies was determined in cultured progenitors obtained before and 1 year after treatment initiation

AOP2014 / P1101 vs. JAK2V617F(²Ä23­¶)

In vivo: PROUD-PV cohort

•BM progenitors could be studiedin 10/13 French pts, 3 treated with AOP2014 and 7 with HU

•ratio of mutant to wild-type JAK2colonies was determined in cultured progenitors obtained before and 1 year after treatment initiation

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Âå¥Í´N¬O¨S¦³¿ï¾Ü¡A¤~·| lable-off use HU ªvÀø PV ¡C Âå¥Í¶}ÃĬO¬°¤FªvÀø¡AHU ¥Î¤[¤F·|¨Cªp·U¤U¡AHU °£¤F«K©y¤§¥~¡A¨S¦³ÀuÂI¥i¨¥¡C­Y¦³¼Ð·Ç¥¿³W¥ÎÃÄ¡Aªø´Á¨Ï¥Î¤]¯àí©w¯f±¡¬Æ¦Üªv¡¡A·Q¤£¥X¨Ó¦³¤°»ò²z¥ÑÂå¥Í¦A¶} HU ¡C

HU ·|¤£·|­PÀù¡AÂå¬É©|¥¼©w½×¡A¥uª¾¹D PV ±wªÌªA¥Î HU ¦³¾÷²v±o AML ¡AÁ{§ÉÆ[¹î¤W¤]½T¹ê¦³µo²{¡A¦ý¬O¤£¬O¦]¬° HU ªºÃö«Y¡A¨S¦³Á{§É¼Æ¾ÚÀò±oÃÒ¹ê¡C

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¤@¡BRichard T. Silver¡G

(¤@)Treatment of polycythemia vera with recombinant interferon alpha (rIFN£\)

(¤G)Conclusions¡G

1.Interferon is probably the best treatment to control the proliferative aspects of polycythemia vera

¡VBiological basis for its use

¡VAble to induce clinical, hematological and some degree of molecular remission

2.All interferons are qualitatively effective, but like all potent medications, have side effects.

Peg-IFNs may have superior quantitative effect. RoPegmost promising.

3.Significance of molecular remission still not clear. Marrow fibrosis and hypercellularitypersist even with low JAK2 allele burden.

4.MPNs should probably be treated earlier rather than later (Silver, Hasselbalch, Gisslinger, Kiladjian and probably others).

5.JAK2inhibitors in combination with interferon for symptomatic relief, increased rate of molecular remission? Effect on fibrosis?

¤G¡BJ.J. Kiladjian

(¤@)Can we alter MPN evolution with IFNtherapy?

(¤G)Conclusion

•IFNalpha is the only drug able to induce significant rates of clinical, hematological, histopathologicaland molecular responses in MPNpatients

•Reducing the mutant allele burden could translate in higher probability of:

remaining in complete hematological response without therapy

longer event free survival

•Early treatment with IFNcould also be a key factor to alter disease evolution

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AOP¥ô©R·sªºÀç¹Bªø¡A·Ç³Æ±À¥X¦å²G¾Ç»â°ì·s²£«~¡C

Miroslaw Jan Lubecki ¡V newly appointed Chief of Commercial Operations

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The internationally active, Vienna-based pharmaceutical company AOP Orphan, which specializes in rare diseases, has appointed Miroslaw Jan Lubecki MD, MBA to join the management team as Chief of Commercial Operations.

At AOP Orphan, Miroslaw Jan Lubecki will first concentrate on preparing the organization for future challenges including expansion into new markets. Simultaneously he will prepare the launch of new products in the areas of Hematology and Gastroenterology.

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¸É¥R£¸ÂI:­Ó¤H§ë¸êÃĵجOı±oP1101¦³µÛ£¸ºØ¦A©óPV¦å²G¥«³õ¸Ì¦³¨ä§Ö­n¿W¦û¥«³õªº·Pı,±N¨Ó¥²µo¥úµo¼ö¡A¥t¥~¬ü°êET,C¨x+¤p¤À¤l3´Á¤½¥qÁ{§É¦ó®É±À°Ê(¬°¦óET¨S¼Ú¬w)¡A±N¨ÓLow Risk PV IIT ¬O§_¦³¾÷·|·m­¹¨ä§ó¼s¤j¥«³õ?Åý§Ú­ÌÄ~Äò¬Ý¤U¥h...
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The net product revenue of Jakafi, which was $136 million in 2012, rose to $235 million in 2013; $358 million in 2014; $601 million in 2015 and $853 million in 2016. Looking ahead to 2017, the Company expects Jakafi net product revenue to range between $1.02 billion to $1.07 billion.

Read more: http://www.nasdaq.com/article/company-spotlight-incyte-20170413-00737#ixzz4eC8QGSwA

http://www.nasdaq.com/article/company-spotlight-incyte-20170413-00737

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A Patient¡¦s Story: My Clinical Trial Experiences

Posted on April 4, 2017 by MPN Advocacy & Education

http://mpnadvocacy.com/2017/04/a-patients-story-my-clinical-trial-experiences/

 

At what point in your MPN diagnosis did you join a clinical trial?  What trial (drug) were you in?

I was diagnosed with PV in 2001.  Only on phlebotomy and 81mg aspirin until 2007 when I began hydroxyurea because I turned 60 in 2006 and was now ¡§high risk.¡¨  In 2009 my spleen was enlarging. I had been hearing that Interferon was best taken in the early stage of MF and might reduce myelofibrosis.  My hematologist advised me he would be having a trial with Pegasys (Interferon) and I should wait for that. I actually waited until 2012 when the trial became available.  I was now showing signs through bone marrow biopsies of secondary MF.

Did you feel as though you received accurate information getting into the trial?

Yes, I had been reading about Interferon treatment and knew I wanted to try it.  Perhaps I didn¡¦t know how quickly I could be removed from the trial because of my worsening symptoms.

What didn¡¦t you know going into the trial that would be useful for others to know or questions they might ask?

It would have helped to know at what point you may be pulled from the trial and what happens after you are removed.  Also, I did not know that the FDA can shut a trial down at any point due to adverse reactions to few patients.

How many clinical trials have you participated in?

I am currently on my 3rd clinical trial.  (First trial wasn¡¦t improving my symptoms, second trial was shut down by the FDA and the pharma company decided not to proceed , and the third trial I have begun my 4th year.)

Were you able to get the drugs after the trial(s) if you were doing well?

I can continue with the drug I am currently on as long as I continue to have benefit and as long as there is funding for this drug by the pharma company, and that it doesn¡¦t get shut down prior to FDA approval

What advice would you impart to those who are skeptical about clinical trials who are not doing well on available treatments?

What do you have to lose?  If you are currently not well, you certainly may have good results and feel better.  If you don¡¦t show benefit you will be removed to try something else.  We do not know the future after taking these drugs.  That is a gamble we must take.

Would you participate in other trials knowing what you know now?  

If I was not feeling well and I met the qualifications, I would try again.

Marylin C. has been living with her diagnosis for many years.  She has graciously volunteered for trials not only for her own reasons, but for the sake of MPN patients and their futures.

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MPN Asia The 2nd Annual International Symposium on Myeloproliferative Neoplasms on April 1, 2017

Dr. Kiladjian Can We Alter MPN Evolution with IFN Therapy?

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Thank you for your nice talk! Hope that quantification of JAK2V617F allele burden would be a marker for IFN therapy.

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¥H¬ãµo¾É¦V¡A¥þ¥@¬É¬°»R¥xªº¤½¥q¡Aª¾ÃѪº©µ¦ù»P¬y°Ê¬O«D±`­«­nªº¡C

³o¤Q´X¦~¨Ó§Ú©Òª¾¹Dªº³o´X¦ì¬ì¾Ç®a¡A¤£·|¶Ãªá¿ú¡A§ó¬Û«H³£¬O¦b°l¨D¤½¥q§ó¦hªº¦¨ªø¡C

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«H®É¶¡¨ì¤F¥L­Ì·|¦³¥¿¦¡ªº»¡©ú¡C

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¬°¦óªi¤h¹y¬O¥þ¥@¬É³Ì±jªº¥ÍÂå»E¸¨¡C

Sanofi, Pfizer, Biogen-Idec, Novartis all major pharmaceutical companies with large research centers just outside Boston, employ over 10,000 people alone.

ªuµÛ¬d²zªeKendlesquare¡A«Ü¤p¦a°Ï»E¶°¤F°ª¯À½èªº¥ÍÂå¤H¤O¡A

¤£ºÞ¬O¤H¤~ªº¬y³q¡A¸êª÷ªº§ä´M¡A¨«­Ó¸ô´N¥i¥H¸I­±¡C

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Ãĵرq¥x¥_¥«¶é°Ï¸ô¤T¸¹¡A¨ìºû¤]¯Ç(AOP¹Ù¦ñ)¡BªF¨Ê¡Bªi¤h¹y¤À¤½¥q¡B·s¦Ë¥ÍÂå¶é°Ï¡A³£¦³²`²`ªº¾Ô²¤¦Ò¶q¡C

http://www.liftstream.com/boston-biotech-cluster.html

https://www.thebalance.com/boston-and-san-francisco-biotech-hubs-375641

http://www.xconomy.com/national/2012/10/08/watch-out-sf-boston-is-becoming-biotechs-no-1-cluster/

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¬ì§Þ³¡¬ì¾Ç¤u·~¶é°Ï¼fij©e­û·|²Ä32¦¸·|ij3¤ë28¤é¥l¶}¡A·|¤¤³q¹LÃĵØÂåÃĪѥ÷¦³­­¤½¥q·s¦Ë¤À¤½¥q¡BÃv¥ÍÂå¹qªÑ¥÷¦³­­¤½¥q¡B¤é­p¤u·~ªÑ¥÷¦³­­¤½¥qµ¥3®a¼t°Ó¶i¾n·s¦Ë¬ì¾Ç¶é°Ï¡A§ë¸êÁ`ÃB¦X­p11.79»õ¤¸¡C¼fij©e­û·|¦P®É³q¹L5¥ó¼o¤î®×¡A2¥ó¼W¸ê³Æ¬d®×¡A¦X­p¼W¸ê·s¥x¹ô1.8»õ¤¸¡A¤Î1¥ó·s¼W²£«~Àç·~¶µ¥Ø¡C

¢iÃĵØÂåÃĪѥ÷¦³­­¤½¥q·s¦Ë¤À¤½¥q¡]³]¥ß©ó·s¦Ë¬ì¾Ç¤u·~¶é°Ï¥ÍÂå¶é°Ï¡^

ÃĵØÂåÃÄ·s¦Ë¤À¤½¥qÀç¹B¸êª÷·s¥x¹ô10»õ¤¸¡A§ë¸ê¤H¬°ÃĵØÂåÃĪѥ÷¦³­­¤½¥q¡FÃĵØÂåÃÄ(ªÑ)¤½¥q¦¨¥ß©ó89¦~5¤ë¡A¦h¦~¨Ó­P¤O©ó·sÃĶ}µo¨Ã¥Ó½Ð¦h¶µ±M§Q¡A¦¨¥\¶}µo¥X°ª«×©w¦ì(>90%)ªºPEG½¢¦X¤ÏÀ³§Þ³N¥­¥x¡C¸Ó±M§Q§Þ³N¥­¥xµo®i¥X¤@¨t¦Cªº°ª«×©w¦ìªø®Ä«¬³J¥Õ½è·sÃÄ«~¡C

ÃĵØÂåÃÄ·s¦Ë¤À¤½¥q©Ò¶}µoªºPEGªø®Ä«¬£\-2b ¤zÂZ¯ÀÄÝ©ó·s¤@¥N§ï¨}ª©ªø®Ä«¬¤zÂZ¯À¡A¨ã³Æ°ª¯Â«×¡]¡Ö95¢H¡^¡B±wªÌ­@¨ü«×°ª¡]¨ã°ª­@¨ü¾¯¶q¡^¡B°Æ§@¥Î¤j´T´î§Cµ¥ÀuÂI¡A¥iÀ³¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g¤ÎºC©Ê¨xª¢¡A¨Ã¤w¦¨¥\¶}µo¦h¶µ±M§Q¡C

ÃĵØÂåÃÄ·s¦Ë¤À¤½¥q©Ò´x´¤ªº®Ö¤ß±M§Q«Y§Q¥Î¦Û¦æ³Ð·s¬ãµoªºPEGylation§Þ³N¥­¥x©M¬ð¯}©Êªº¤Æ¾Ç½¢¦X§Þ³N¡A¦¨¥\¦a¦bPEG©M£\¤zÂZ¯À¶¡´¡¤J¤@­ÓÓi°ò»Ä¡A§Î¦¨¤@­Ó¤Æ¾Ç¤Wí©w¥B95¢H¥H¤W³æ¤@¦¨¤Àªº·s¤@¥NPEGªø®Ä«¬£\¤zÂZ¯À¡]P1101¡^¡A¦¹ÃĪ«¥iÀ³¥Î¦b¨u¨£¦å²G¯e¯f¤Î¨xŦ¯e¯fµ¥¦hºØ¤£¦P¾AÀ³¯g¡A¥«³õ«e´º·¥¨Î¡C

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¤@¡B²Ä¤G©¡°ê»Ú°©Åè¼W¥Í©Ê¸~½F¬ã°Q·|

The 2nd Annual International Symposium on Myeloproliferative Neoplasms

(¤@) Dr. Ruben Mesa¡A MPN Disease Burden: Lessons Learned from Patients

(¤G) Dr. Richard Silver¡A IFN Treatment for PV

¨ä¤¤Dr. Ruben Mesa¤ÎDr. Richard SilverºtÁ¿ÃD¥Ø»P¤U¦C¸ê®Æ¤£ª¾¤º®e¬O§_§¹¥þ¤@¼Ë¡C¥i°Ñ¦Ò¤U¦Cºô§}¤§ (powerpoint)

¤G¡B 2017 Presentations

(¤@)Ruben Mesa, What MPN Patients have Taught Us?

http://www.mpninfo.org/pdf/08.pdf

(¤G)Richard Silver, Is PV Curable with Interferon?

http://www.mpninfo.org/pdf/06.pdf

¦b²Ä27­¶´£¤ÎRopeginterferon alpha 2b (RoPEG£\2b)

(¤T)Claire Harrison, ET Yesterday, Today and Tomorrow

http://www.mpninfo.org/pdf/04.pdf

¦b²Ä19­¶Ongoing Studies of IFN£\ in PV + ET

´£¤Îpeg-IFN-2b (ropeginterferon -2b )

Phase 2 completed (PEGINVERA)

Phase 3 ompleted (PROUD-PV) HU and IFN equivalent

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§®...§®...§®...¦h¦¸...ªø´Á§Q¦h,ªÑ»ù½w¨B¤Wº¦.ªñ§Q¦h®ø®§®É´Á,ªÑ»ù½w¨B¤U¶^,ÁÙ§C¹L¥¼µo¥¬®ø®§«e.¬°¦ó¤£¦b«e¬qªÑ»ù¨B¦V¤Wº¦®É¥X²æ,¦Ó¦b§Q¦h®ø®§«e¥BªÑ»ù§CÂI³B±ó¦u? ·s¤â¤£©ú³B,½Ð°ª¤H¶}ÄÀ,ÁÂÁÂ.
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Ãĵأ¸¨B£¸¨B©¹°ê»ÚÁÚ¶i¡A¨Ì³Ìªñ°ê²¼§ë¸ê½×¾Âªk»¡·|¨Ó¬Ýªº¸Ü¡A¦p¹w´Á2018¦~PVÃÄÃÒ¨ì¤â.2020¦~©³ET¤ÎC¨xÃÄÃÒ¤]¦p¹w´Á¨ì¤â¡A2020¦~¦³¾÷·|¬D¾Ô¥Í§ÞªÑ¤ýÄ_®y¡A¨Ì¾P°â3¨ì5¦~ªºº¯³z²v¡A2025¦~¦³¾÷·|¬D¾Ô¤j¥ß¥úÄ_®y(2009¦~167¤¸¡÷2013¦~¯}¤d)ªÑ»ù°_°_¸¨¸¨¤]¼vÅT¤F±¡ºü¡A°ò¥»­±¤£ÅÜ¡A©ñµÛ´N¹ï¤F!!¥[ªo!¦U¦ìµØ¤Í¤j¤j­Ì!!
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Ãĵإ[ªo°Ú¡A¤@ª½¦b¤ä«ù§A¡A¤]¤@ª½¦bµ¥«Ý

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¤é¥»¦å²G¨ó·|

http://www.jshem.or.jp/

²{¥ô²z¨Æªø

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Dr. Koichi Akashi

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¦¹¦¸«h¥Ñ¤é¥»¦å²G¯f¾Ç·|±µÄò¥D¿ì¡AÁܽХ]¬A¼Ú¬w¡B¬ü°ê¡B¤é¥»¡B¥xÆWµ¥­«¶q¯Å

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±a°Ê¤j®a¹ï¦å²G¯e¯fªvÀøªº­«µø¡A¥H¤Î¹ï·s¤@¥N¤zÂZ¯À¬°°ò¦ªvÀø¤è¦¡ªº¶i¤@¨B»{ÃÑ¡C

ÃĵØÃĸɥR¡A¥»¦¸¬ã°Q·|¥Ñ¤é¥»¦å²G¾Ç·|¥D¿ì¡A²{¥ô¥D®u¨ª¥q¯E¤@³Õ¤h

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¾ã³õ·|ij°£»EµJ±´°Q°©Åè¼W¥Í©Ê¸~½F¥H¤Î¥Ø«e°ê»Ú¤W³Ì·sÃĪ«ªº¶}µoÁͶջP¯f²z¥~¡A

§óÁܽаê»Ú¦å²G¾Ç·|±`°È²z¨Æ·|¥D®uRuben MesaÂå¾Ç³Õ¤hµoªí¼öªù¥DÃD

¡uMPN¯e¯f­t¾á¡G±q¯f±w¨­¤W¾Ç¨ìªº½ÒÃD¡v¡C

Ruben Mesa­P¤O©ó§ïµ½°©Åè¼W¥Í©Ê¸~½F±wªÌªºªvÀø©M¥Í¬¡½è¶q¤§ÃĪ«¬ã¨s¡A

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¥H¤Î¨È¬w¦a°ÏÂåÀø°ò¦³]¬Iªº±j¤Æ¡A¥[¤W³\¦h·sÀøªkªº¥X²{¡A

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2017/03/14(http://www.appledaily.com.tw/realtimenews/article/finance/20170314/1075228/applesearch)

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(6446) ÃĵØÂåÃĦX§@¹Ù¦ñAOP¤½¥q«Å¥¬EMA ¨ü²zP1101¥Î©óPV¾AÀ³¯gªº·sÃĤW¥«³\¥i¥Ó½Ð

AOP Orphan Pharmaceuticals AG announces start of EMA marketing authorization application procedure for Ropeginterferon alfa-2b in Polycythemia Vera

www.aoporphan.com/en/news-media/startpage-detail/artikel/aop-orphan-pharmaceuticals-ag-announces-start-of-ema-marketing-authorization-application-procedure-for-ropeginterferon-alfa-2b-in-polycythemia-vera.html

# 14.03.2017

* EMA started the centralized marketing authorization procedure for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) on Feb 23rd 2017.

EMA ¤w©ó2017¦~2¤ë23¤é¥¿¦¡±Ò°Ê¹ï©óÃĵØÂåÃÄ P1101 ¦bPV¾AÀ³¯g¤W¥«¼f®Ö¡C

* Ropeginterferon alfa-2b is a novel mono-pegylated interferon with an improved every-two-week application schedule and orphan designation in Europe and the U.S.

P1101¬O¤@­Ó³Ð·sªº¡B³æ¤@»E¤A¤G¾Jªº¤zÂZ¯À¡A¶È»Ý­n¨C¨â©P¬I¥´¤@¦¸¨Ã¥B¦b¼Ú¬ü¨ú±o©t¨àÃÄ»{©w¡C

* AOP¡¦s development program in PV consistently demonstrated convincing efficacy, safety, tolerability, convenience and compliance.

AOP ¦b PV ¾AÀ³¯g¤Wªº¬ãµo¯à¤Oºû«ù¹L¥h¤@³eªºªí²{, ¤£ºÞ¦bÀø®Ä¡B¦w¥þ©Ê¡B­@¨ü«×¡B«K§Q©Ê©M¯f¤H¥ÎÃĶ¶±q©Ê³£®i²{¥O¤H«H¿àªº¦¨ªG¡C

* Data from AOP´s development program will be presented to U.S. FDA for approval for commercialization in the U.S. by PharmaEssentia.

ÃĵØÂåÃijW¹º±N¥H³o¨ÇÁ{§É¼Æ¾Ú§@¬°¥Ó½Ð¬ü°êFDAÃÄÃÒ¤W¥«®Ö­ã¤§¸ê®Æ¡A¥H¨ú±o¤W¥«®Ö¥i¡C

* PharmaEssentia discovered Ropeginterferon alfa-2b and exclusively licensed the development and commercialization rights for myeloproliferative neoplasms in Europe, CIS and Middle Eastern markets to AOP Orphan.

P1101¬O¥ÑÃĵØÂåÃÄ©Ò¬ãµo¡AÃĵØÂåÃĤw±NMPNs¾AÀ³¯g¦b¼Ú¬w¡B«eĬÁp¿W¥ß°ê(Commonwealth of Independent States)¡B¤¤ªFµ¥¦a°Ïªºµo®i»P¥«³õ¦æ¾Pµ¥Åv§Q±MÄݱ¤©AOP¤½¥q¡C

Vienna, March 14th 2017: AOP Orphan Pharmaceuticals AG (AOP Orphan) announced the start of the EMA marketing authorization application procedure (centralized procedure) for the European licensure of

Ropeginterferon alfa-2b in Polycythemia Vera (PV) on Feb 23rd 2017.

2017¦~3¤ë14¤é¦ì©óºû¤]¯ÇªºAOP¤½¥q«Å¥¬P1101¦bPV¾AÀ³¯gªº¼Ú¬w¤W¥«³\¥i»{ÃÒ°e¥ó¥Ó½Ðµ{§Ç¤w©ó2017¦~2¤ë23¤é¶}©l¡C

Ropeginterferon alfa-2b, a novel, long-acting, mono-pegylated proline interferon, uniquely administered once every two weeks, is expected to be the first interferon approved for PV worldwide and the only approved first-line treatment for PV in the U.S. The drug has an orphan designation in both Europe and the U.S.

Ropeginterferon alfa-2b (P1101)¡A¬O¤@­Ó³Ð·sªº¡Bªø®Äªº¡B³æ¤@»E¤A¤G¾Jªº²ãÓi»Ä(Proline)¤zÂZ¯À¡A¥i¨C¨â©Pª`®g¤@°w¡F¹w´Á¥i¥H¦¨¬°¥þ²y²Ä¤@­Ó§å­ã¥Î©óªvÀøPVªº¤zÂZ¯À¥H¤Î¬ü°ê°ß¤@¤@ºØ³Q§å­ã¥Î©óPV¤@½u¥ÎÃĪvÀøªºÃĪ«¡CP1101¦b¼Ú¬ü§¡Àò±o©t¨àÃÄ»{©w¡C

Key results from AOPs development program in PV have been announced earlier:

AOP ¦bPV¾AÀ³¯gªº·sÃĬãµo­pµe¥ý«e©Ò«Å¥¬ªº´X¶µ¦¨ªG¡G

In the ongoing phase II trial PEGINVERA patients have been treated with Ropeginterferon alfa-2b for up to over 5 years, showing convincing efficacy and tolerability. Notably, all remaining patients are maintained on a convenient once-a-month dosing regimen.

«ùÄò¶i¦æªºÁ{§ÉII´ÁÁ{§É¸ÕÅ礤¥i¥H¬Ý¨ì¡APV¯f±w«ùÄò±µ¨üP1101ªvÀøªø¹F5¦~¥H¤Wªº®É¶¡¡CÁ{§É¸ÕÅ窺ªvÀø¦¨ªG§e²{¥X¥O¤H«H¿àªºÀø®Ä¥H¤Î¯f¤H¨}¦nªº­@¨ü«×¡C­È±oª`·Nªº¬O¡A¥Ø«e©Ò¦³«ùÄò°Ñ»PªvÀøªº¯f±w§¡ºû«ù¨C¤ëµ¹ÃĤ@¦¸ªº«K§Q©Ê¡C

In the phase III trial PROUD-PV, Complete Hematologic Response (CHR) was achieved in a high proportion of patients and non-inferiority to hydroxyurea (HU) was demonstrated (43.1% for Ropeginterferon alfa-2b versus 45.6% for HU in the intent-to-treat-population, p=0.0028) at 12 months. Ropeginterferon alfa-2b showed significantly better tolerability than HU. The ongoing phase III extension study CONTINUATION-PV will add long-term data.

¦bPROUD-PVÁ{§É¤T´Áªº¸ÕÅ礤¡AÅã¥Ü¥X·¥°ª¤ñ¨Òªº¯f±w¹F¨ì§¹¥þ¦å²G¾Ç¤ÏÀ³(CHR)¥B»P¨Ï¥Î·Rªv½¦Ån(Hydroxyurea, HU) ±wªÌ¦b12­Ó¤ëªºÀøµ{¤¤§e²{¥X«D¦H©Êµ²ªG (¦b·N¹ÏªvÀø±Ú¸s²Õ§e²{P1101 ²Õ¬°43.1% ¦Ó HU²Õ¬°45.6%ªº¦å²G¾Ç¤ÏÀ³µ²ªG, p­È=0.0028 )¡CP1101 ©úÅã§e

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AOP Orphan Pharmaceuticals AG announces start of EMA marketing authorization application procedure for Ropeginterferon alfa-2b in Polycythemia Vera

EMA started the centralized marketing authorization procedure for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) on Feb 23rd 2017.

Ropeginterferon alfa-2b is a novel mono-pegylated interferon with an improved every-two-week application schedule and orphan designation in Europe and the U.S.

AOP´s development program in PV consistently demonstrated convincing efficacy, safety, tolerability, convenience and compliance.

Data from AOP´s development program will be presented to U.S. FDA for approval for commercialization in the U.S. by PharmaEssentia.

PharmaEssentia discovered Ropeginterferon alfa-2b and exclusively licensed the development and commercialization rights for myeloproliferative neoplasms in Europe, CIS and Middle Eastern markets to AOP Orphan.

Vienna, March 14th 2017: AOP Orphan Pharmaceuticals AG (AOP Orphan) announced the start of the EMA marketing authorization application procedure (centralized procedure) for the European licensure of Ropeginterferon alfa-2b in Polycythemia Vera (PV) on Feb 23rd 2017.

Ropeginterferon alfa-2b, a novel, long-acting, mono-pegylated proline interferon, uniquely administered once every two weeks, is expected to be the first interferon approved for PV worldwide and the only approved first-line treatment for PV in the U.S. The drug has an orphan designation in both Europe and the U.S.

Key results from AOPs development program in PV have been announced earlier: 

In the ongoing phase II trial PEGINVERA patients have been treated with Ropeginterferon alfa-2b for up to over 5 years, showing convincing efficacy and tolerability. Notably, all remaining patients are maintained on a convenient once-a-month dosing regimen.

In the phase III trial PROUD-PV, Complete Hematologic Response (CHR) was achieved in a high proportion of patients and non-inferiority to hydroxyurea (HU) was demonstrated (43.1% for Ropeginterferon alfa-2b versus 45.6% for HU in the intent-to-treat-population, p=0.0028) at 12 months. Ropeginterferon alfa-2b showed significantly better tolerability than HU. The ongoing phase III extension study CONTINUATION-PV will add long-term data. 

Importantly, interferons are the only known treatment modality with the potential for disease modification, which is believed to improve progression-free survival and long-term outcomes.

Professor Heinz Gisslinger from the Medical University of Vienna, the principal investigator in AOP´s development program said, ¡§Interferons have been used successfully in myeloproliferative neoplasms for over 30 years, now Ropeginterferon alfa-2b is expected to be the first interferon to be licensed in these indications. Study data confirm the expected efficacy, while safety and tolerability appear superior in comparison to previously reported data on other interferons.¡¨ 

¡§AOP Orphan has continuously invested over many years into development of treatments in the field of MPNs. The successful validation of the centralized marketing authorization procedure in Europe via EMA for Ropeginterferon alfa-2b as an orphan designated medicine is a further milestone in our long term commitment to providing drugs for patients with rare diseases.¡¨ said Rudolf Widmann, Ph.D. founder and CEO of AOP Orphan.

Ko-Chung Lin, Ph.D., founder and CEO of PharmaEssentia, added, ¡§PharmaEssentia has successfully developed the technology to drive long-acting interferon beyond the weekly dosing regimen. The advantages provided by Ropeginterferon alfa-2b, apparent by its promising Phase III data and prior studies, along with our state-of-the-art manufacturing facility in Taiwan, collectively bring us closer to offer efficacious and safe therapies for the treatment of myeloproliferative neoplasms such as PV, myelofibrosis, chronic myeloid leukemia, as well as hepatitis

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Conference Name

2nd Annual International Symposium on Myeloproliferative Neoplasms (MPN Asia 2017)

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Date

Saturday, April 1, 2017

3F Conference Room, GIS MOTC Convention Center

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Secretariat of MPN Asia 2017

Content Ed Net Taiwan Limited

Sophia Wang (Ms.)

02-2729-6399

sophia.wang@contentednet.com

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The 2nd Annual International Symposium on Myeloproliferative Neoplasms

®É¶¡2017-04-01ªº09:00¦Ü17:50

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09:00 ¡V 09:30 Registration

09:30 ¡V 09:35 Welcome Remarks Dr. Koichi Akashi

09:35 ¡V 09:40 Opening Remarks Dr. Norio Komatsu Basic Science of MPN

09:40 ¡V 10:15 Mutations in MPN: Hereditary Predispositions, Disease Initiators and Drivers of Progression Dr. Robert Kralovics

Dr. Robert Kralovics Dr. Norio Komatsu

10:15 ¡V 10:40 The Role of Wild and Mutant Calreticulin in Hematopoiesis

Dr. Kazuya Shimoda

10:40 ¡V 11:05 Molecular Mechanisms Leading to the Development of Myeloproliferative Neoplasms by Mutant Calreticulin

Dr. Marito Araki

11:05 ¡V 11:25 The role of HMGA2 in MPN Dr. Chih-Cheng Chen MPN Pathology

11:25 ¡V 12:05 New WHO Classification of Myeloproliferative Neoplasms Dr. Hans-Michael Kvasnicka Dr. Masafumi Ito

12:05 ¡V 13:00 Lunch Hot Topic of MPN

13:00 ¡V 13:35 MPN Disease Burden: Lessons Learned from Patients Dr. Ruben Mesa Dr. Yuzuru Kanakura Asian MPN Session

13:35 ¡V 13:55 Childhood Myeloproliferative Neoplasms Dr. Jong Jin Seo

Dr. Keita Kirito Dr. Dong-Tsamn Lin

13:55 ¡V 14:15 Clinical Outcomes of Patients with Primary Myelofibrosis in Japan: A Report of a Nationwide Survey from 1999 to 2015

Dr. Katsuto Takenaka

14:15 ¡V 14:35 Primary Myelofibrosis in Taiwan Dr. Lee-Yung Shih

14:35 ¡V 14:55 Chronic Neutrophilic Leukemia: Experience from China Dr. Qian Jiang

14:55 ¡V 15:15 Coffee Break IFN Renaissance

15:15 ¡V 15:40 IFN Treatment for PV Dr. Richard Silver

Dr. Jean-Jacques Kiladjian Dr. Srdan Verstovsek

15:40 ¡V 16:00 Long Term Results of Peg-IFN Therapy in PV and ET

Dr. Srdan Verstovsek

16:00¡V 16:20 Results of the PROUD-PV Study Dr. Heinz Gisslinger

16:20 ¡V 16:40 Molecular Landscape of MPN: Influence on Response to Therapy and Evolution Under Treatment with Interferon Alpha Dr. Bruno Cassinat

16:40 ¡V 17:00 Can We Alter MPN Evolution with IFN Therapy? Dr. Kiladjian

17:00 ¡V 17:20 New Antiviral Mechanism of Interferon on Hepatitis B virus Dr. Pei-Jer Chen, MD Panel Discussion

17:20 ¡V 17:45 Chair: Dr. Jean-Jacques Kiladjian & Dr. Srdan Verstovsek

17:45 ¡V 17:50 Closing Remarks Dr. Katsuya Shimoda

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